Sunday, 23 August 2015

Guidance for importers of medicinal products

The
European Medicines Agency has issued a new concept paper “Guidance for
importers of medicinal products.”

The
paper poses and addresses the following problem statement:

“The
increased complexity of supply chains and the observation that most GMP
non-compliance statements uploaded into EudraGMDP pertain to third country
manufacturers have created new areas where further guidance is desired by both
the regulators and the industry. In particular, the requirements applicable to
importers of medicinal products and concerning the application of GMP
requirements, which are traditionally oriented to activities performed at true
manufacturing sites.”